|Publication number||US8038670 B2|
|Application number||US 11/318,207|
|Publication date||18 Oct 2011|
|Filing date||22 Dec 2005|
|Priority date||6 Mar 2000|
|Also published as||EP1487365A1, EP1487365A4, US7998140, US8048070, US8568409, US20040019350, US20050015085, US20050059966, US20060106379, US20080058796, WO2003082134A1, WO2003082134A8|
|Publication number||11318207, 318207, US 8038670 B2, US 8038670B2, US-B2-8038670, US8038670 B2, US8038670B2|
|Inventors||Michael E. McClurken|
|Original Assignee||Salient Surgical Technologies, Inc.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (102), Non-Patent Citations (92), Referenced by (1), Classifications (28), Legal Events (8)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application is a continuation of U.S. application Ser. No. 10/365,170, filed Feb. 11, 2003, which claims priority under 35 U.S.C. §119(e) to U.S. provisional application Ser. Nos. 60/356,390, filed Feb. 12, 2002, and 60/368,177, filed Mar. 27, 2002, and which is a continuation-in-part of U.S. application Ser. No. 09/947,658, filed Sep. 5, 2001, issued as U.S. Pat. No. 7,115,139 which is a continuation-in-part of U.S. application Ser. No. 09/797,049, filed Mar. 1, 2001, issued as U.S. Pat. No. 6,702,810 which claims priority to U.S. provisional application Ser. No. 60/187,114, filed Mar. 6, 2000. The entire disclosures of these applications are incorporated herein by reference.
This invention relates generally to the field of medical devices and methods for use upon a body during surgery. More particularly, the invention relates to electrosurgical devices, systems and methods for use upon tissues of a human body during surgery, particularly open surgery and minimally invasive surgery such as laparoscopic surgery.
Electrosurgical devices configured for use with a dry tip use electrical energy, often radio frequency (RF) energy, to cut tissue or to cauterize blood vessels. During use, a voltage gradient is created at the tip of the device, thereby inducing current flow and related heat generation in the tissue. With sufficiently high levels of electrical energy, the heat generated is sufficient to cut the tissue and, advantageously, to stop the bleeding from severed blood vessels.
Current dry tip electrosurgical devices can cause the temperature of tissue being treated to rise significantly higher than 100° C., resulting in tissue desiccation, tissue sticking to the electrodes, tissue perforation, char formation and smoke generation. Peak tissue temperatures as a result of RF treatment of target tissue can be as high as 320° C., and such high temperatures can be transmitted to adjacent tissue via thermal diffusion. Undesirable results of such transmission to adjacent tissue include unintended thermal damage to the tissue.
The use of saline inhibits such undesirable effects as sticking, desiccation, smoke production and char formation. One key factor is inhibiting tissue desiccation, which occurs when tissue temperature exceeds 100° C. and all of the intracellular water boils away, leaving the tissue extremely dry and much less electrically conductive. However, an uncontrolled or abundant flow rate of saline can provide too much cooling at the electrode/tissue interface. This cooling reduces the temperature of the target tissue being treated, and the rate at which tissue thermal coagulation occurs is determined by tissue temperature. This, in turn, can result in longer treatment time to achieve the desired tissue temperature for treatment of the tissue. Long treatment times are undesirable for surgeons since it is in the best interest of the patient, physician and hospital, to perform surgical procedures as quickly as possible.
RF energy delivered to tissue can be unpredictable and often not optimal when using general-purpose generators. Most general-purpose RF generators have modes for different waveforms (e.g., cut, coagulation, or a blend of these two) and device types (e.g., monopolar, bipolar), as well as power levels that can be set in watts. However, once these settings are chosen, the actual power delivered to tissue and associated heat generated can vary dramatically over time as tissue impedance changes over the course of RF treatment. This is because the power delivered by most generators is a function of tissue impedance, with the power ramping down as impedance either decreases toward zero or increases significantly to several thousand ohms. Current dry tip electrosurgical devices are not configured to address a change in power provided by the generator as tissue impedance changes or the associated effect on tissue and rely on the surgeon's expertise to overcome this limitation.
The invention is directed to various embodiments of electrosurgical devices. In one preferred embodiment, an electrosurgical device has a proximal end and a distal end, with the device having a handle and a shaft extending from the handle, an electrode tip having an electrode surface, at least a portion of the electrode tip extending distally beyond the distal end of the shaft, with the electrode tip extending distally beyond the distal end of the shaft comprising a cylindrical side surface and a domed distal end surface. The device also has a fluid passage connectable to a fluid source, and at least one fluid outlet opening in fluid communication with the fluid passage, the fluid outlet opening located proximal to the domed distal end surface of the electrode tip and arranged to provide a fluid from the fluid source to the cylindrical side surface of the electrode tip.
In another preferred embodiment, the electrode tip extending distally beyond the distal end of the shaft has a neck portion and an enlarged end portion, the enlarged end portion located distal to the neck portion and comprising a cylindrical side surface and a domed distal end surface.
The electrosurgical device may have one or multiple fluid outlet openings, for example four, which can be located at or adjacent the distal end of the shaft. The openings may be equally spaced. These fluid outlet opening(s) may be arranged to provide the fluid from the fluid source around the cylindrical side surface of the electrode tip.
Various other embodiments have a portion of the electrode surface forming a contact angle (θ) with the fluid from the fluid source of less than 90 degrees. Generally, this fluid at least partially wets that portion of the electrode surface that forms the contact angle (θ).
The devices of the invention may include one or multiple recesses provided in the electrode tip, the recess providing a fluid flow channel for a flow of the fluid distally along the electrode tip. This recess or recesses are in fluid communication with the at least one fluid outlet opening. Preferably, the number of recesses is equal to the number of fluid outlet openings.
The invention is also directed to a surgical method for treating tissue. The method includes providing tissue having a tissue surface, providing radio frequency power at a power level, providing an electrically conductive fluid at a fluid flow rate, providing an surgical device configured to simultaneously provide the radio frequency electrical power and the electrically conductive fluid to tissue, providing the electrically conductive fluid to the tissue at the tissue surface, forming a fluid coupling comprising the electrically conductive fluid which couples the tissue and the surgical device, providing the radio frequency power to the tissue at the tissue surface and below the tissue surface into the tissue through the fluid coupling, coagulating the tissue without cutting the tissue, and blunt dissecting the tissue after coagulating the tissue.
The fluid from the electrosurgical device can be a coupling that is used to cool the tissue or dissipate heat from the tissue by transferring heat to the fluid. The fluid coupling can dissipate heat from the tissue by boiling. The radio frequency power level, the conductive fluid flow rate, or both can be adjusted based on the boiling. The tissue is generally protected from desiccation by the fluid coupling.
Throughout the description, like reference numerals and letters indicate corresponding structure throughout the several views, and such corresponding structure need not be separately discussed. Furthermore, any particular feature(s) of a particular exemplary embodiment may be equally applied to any other exemplary embodiment(s) of this specification as suitable. In other words, features between the various exemplary embodiments described herein are interchangeable as suitable, and not exclusive.
The invention provides devices, systems and methods that control tissue temperature at a tissue treatment site during a medical procedure. This is particularly useful during surgical procedures upon tissues of the body, where it is desirable to coagulate and shrink tissue, to occlude lumens of blood vessels (e.g., arteries, veins), airways (e.g., bronchi, bronchioles), bile ducts and lymphatic ducts.
The invention includes electrosurgical procedures, which preferably utilize RF power and electrically conductive fluid, to treat tissue. Preferably, a desired tissue temperature range is achieved by adjusting parameters, such as conductive fluid flow rate, to affect the temperature at the tissue/electrode interface.
In one embodiment, the invention provides a control device, the device comprising a flow rate controller that receives a signal indicating power applied to the system, and adjusts the flow rate of conductive fluid from a fluid source to the electrosurgical device. The invention also provides a control system comprising a flow rate controller, a measurement device that measures power applied to the system, and a pump that provides fluid at a selected flow rate.
The invention will be discussed generally with reference to
For example, in addition to the conductive fluid comprising physiologic saline (also known as “normal” saline, isotonic saline or 0.9% sodium chloride (NaCl) solution), the conductive fluid may comprise hypertonic saline solution, hypotonic saline solution, Ringers solution (a physiologic solution of distilled water containing specified amounts of sodium chloride, calcium chloride, and potassium chloride), lactated Ringer's solution (a crystalloid electrolyte sterile solution of distilled water containing specified amounts of calcium chloride, potassium chloride, sodium chloride, and sodium lactate), Locke-Ringer's solution (a buffered isotonic solution of distilled water containing specified amounts of sodium chloride, potassium chloride, calcium chloride, sodium bicarbonate, magnesium chloride, and dextrose), or any other electrolyte solution.
While a conductive fluid is preferred, as will become more apparent with further reading of this specification, fluid 24 may also comprise an electrically non-conductive fluid. The use of a non-conductive fluid is less preferred than a conductive fluid, however, the use of a non-conductive fluid still provides certain advantages over the use of a dry electrode including, for example, reduced occurrence of tissue sticking to the electrode of device 5. Therefore, it is also within the scope of the invention to include the use of a non-conducting fluid, such as, for example, deionized water.
When capacitation and induction effects are negligibly small, from Ohm's law, power P, or the rate of energy delivery (e.g., joules/sec), may be expressed by the product of current times voltage (i.e., I×V), the current squared times resistance (i.e., I2×R), or the voltage squared divided by the resistance (i.e., V2/R); where the current I may be measured in amperes, the voltage V may be measured in volts, the electrical resistance R may be measured in ohms, and the power P may be measured in watts (joules/sec). Given that power P is a function of current I, voltage V, and resistance R as indicated above, it should be understood, that a change in power P is reflective of a change in at least one of the input variables. Thus, one may alternatively measure changes in such input variables themselves, rather than power P directly, with such changes in the input variables mathematically corresponding to a changes in power P as indicated above.
The RF electrical energy is preferably provided within a frequency band (i.e., a continuous range of frequencies extending between two limiting frequencies) in the range between and including about 9 kHz (kilohertz) to 300 GHz (gigahertz). More preferably, the RF energy is provided within a frequency band in the range between and including about 50 kHz (kilohertz) to 50 MHz (megahertz). Even more preferably, the RF energy is provided within a frequency band in the range between and including about 200 kHz (kilohertz) to 2 MHz (megahertz). Most preferably, RF energy is provided within a frequency band in the range between and including about 400 kHz (kilohertz) to 600 kHz (kilohertz). It should be understood that, for any frequency band identified above, the range of frequencies may be further narrowed in increments of 1 (one) hertz anywhere between the lower and upper limiting frequencies.
While RF electrical energy is preferred, it should be understood that the electrical energy (i.e., energy made available by the flow of electric charge, typically through a conductor or by self-propagating waves) may comprise any frequency of the electromagnetic spectrum (i.e., the entire range of radiation extending in frequency from 1023 hertz to 0 hertz) and including, but not limited to, gamma rays, x-rays, ultraviolet radiation, visible light, infrared radiation, microwaves, and any combinations thereof.
Heating of the tissue is preferably performed by electrical resistance heating. That is, the temperature of the tissue increases as a result of electric current flow through the tissue, with the electrical energy being absorbed from the voltage and transformed into thermal energy (i.e., heat) via accelerated movement of ions as a function of the tissue's electrical resistance.
Heating with electrical energy may also be performed by dielectric heating (capacitation). That is, the temperature of the tissue increases through the dissipation of electrical energy as a result of internal dielectric loss when the tissue is placed in a varying electric field, such as a high-frequency (e.g., microwave), alternating electromagnetic field. Dielectric loss is the electrical energy lost as heat in the polarization process in the presence of the applied electric field. In the case of an alternating current field, the energy is absorbed from the alternating current voltage and converted to heat during the polarization of the molecules.
However, it should be understood that energy provided to heat the tissue may be from surgical devices other than electrosurgical devices, energy sources other than generators, energy forms other than electrical energy and mechanisms other than resistance heating. For example, thermal energy can be provided to the tissue from an energy source having a higher temperature. Such may be provided, for example, by a heated device which heats tissue through direct contact (conduction), through contact with a flowing fluid (convection), or from a remote heat source (radiation).
Also, for example, providing energy to the tissue may be provided via mechanical energy which is transformed into thermal energy via accelerated movement of the molecules, such as by mechanical vibration provided, for example, by an energy source such as a transducer containing a piezoelectric substance (e.g., a quartz-crystal oscillator) that converts high-frequency electric current into vibrating ultrasonic waves which may be used by, for example, an ultrasonic surgical device.
Also, for example, energy can be provided to the tissue via radiant energy (i.e., energy which is transmitted by radiation/waves) which is transformed into thermal energy via absorption of the radiant energy by the tissue. Preferably the radiation/waves comprise electromagnetic radiation/waves which include, but are not limited to, radio waves, microwaves, infrared radiation, visible light radiation, ultraviolet radiation, x-rays and gamma rays. More preferably, such radiant energy comprises energy with a frequency of 3×1011 hertz to 3×1016 hertz (i.e., the infrared, visible, and ultraviolet frequency bands of the electromagnetic spectrum). Also preferably the electromagnetic waves are coherent and the electromagnetic radiation is emitted from energy source such as a laser device.
Referring again to
In one embodiment, flow rate controller 11 is configured and arranged to be connected to a source of RF power (e.g., generator 6), and a source of fluid (e.g., fluid source 1), for example, a source of conductive fluid. The device of the invention receives information about the level of RF power applied to electrosurgical device 5, and adjusts the flow rate of fluid 24 to electrosurgical device 5, thereby controlling temperature at the tissue treatment site.
In another embodiment, elements of the system are physically included together in one electronic enclosure. One such embodiment is shown by enclosure within the outline box 14 of
Pump 3 can be any suitable pump to provide saline or other fluid at a desired flow rate. Preferably, pump 3 is a peristaltic pump. With a rotary peristaltic pump, typically a fluid 24 is conveyed within the confines of a flexible tube (e.g., 4 a) by waves of contraction placed externally on the tube which are produced mechanically, typically by rotating rollers which intermittently squeeze the flexible tubing against a support with a linear peristaltic pump, typically a fluid 24 is conveyed within the confines of a flexible tube by waves of contraction placed externally on the tube which are produced mechanically, typically by a series of compression fingers or pads which sequentially squeeze the flexible tubing against a support. Peristaltic pumps are generally preferred, as the electro-mechanical force mechanism (e.g., rollers driven by electric motor) does not make contact the fluid 24, thus reducing the likelihood of inadvertent contamination.
Alternatively, pump 3 can be a “syringe pump”, with a built-in fluid supply. With such a pump, typically a filled syringe is located on an electro-mechanical force mechanism (e.g., ram driven by electric motor) which acts on the plunger of the syringe to force delivery of the fluid 24 contained therein. The syringe pump may be a double-acting syringe pump with two syringes such that they can draw saline from a reservoir (e.g., of fluid source 1), either simultaneously or intermittently. With a double acting syringe pump, the pumping mechanism is generally capable of both infusion and withdrawal. Typically, while fluid 24 is being expelled from one syringe, the other syringe is receiving fluid 24 therein from a separate reservoir. In this manner, the delivery of fluid 24 remains continuous and uninterrupted as the syringes function in series. Alternatively, it should be understood that a multiple syringe pump with two syringes, or any number of syringes, may be used in accordance with the invention.
Furthermore, fluid 24, such as conductive fluid, can also be provided from an intravenous (IV) bag full of saline (e.g., of fluid source 1) that flows by gravity. Fluid 24 may flow directly to electrosurgical device 5, or first to pump 3 located there between. Alternatively, fluid 24 from a fluid source 1 such as an IV bag can be provided through an IV flow controller that may provide a desired flow rate by adjusting the cross sectional area of a flow orifice (e.g., lumen of the connective tubing with the electrosurgical device 5) while sensing the flow rate with a sensor such as an optical drop counter. Furthermore, fluid 24 from a fluid source 1 such as an IV bag can be provided through a manually or automatically activated device such as a flow controller, such as a roller clamp, which also adjusts the cross sectional area of a flow orifice and may be adjusted manually by, for example, the user of the device in response to their visual observation (e.g., fluid boiling) at the tissue treatment site or a pump.
Similar pumps can be used in connection with the invention, and the illustrated embodiments are exemplary only. The precise configuration of pump 3 is not critical to the invention. For example, pump 3 may include other types of infusion and withdrawal pumps. Furthermore, pump 3 may comprise pumps which may be categorized as piston pumps, rotary vane pumps (e.g., axial impeller, centrifugal impeller), cartridge pumps and diaphragm pumps. In some embodiments, pump 3 can be substituted with any type of flow controller, such as a manual roller clamp used in conjunction with an IV bag, or combined with the flow controller to allow the user to control the flow rate of conductive fluid to the device. Alternatively, a valve configuration can be substituted for pump 3.
Furthermore, similar configurations of the system can be used in connection with the invention, and the illustrated embodiments are exemplary only. For example, the fluid source 1, pump 3, generator 6, power measurement device 8 or flow rate controller 11, or any other components of the system not expressly recited above, may be present as a part of the electrosurgical device 5. For example, fluid source 1 may be a compartment of the electrosurgical device 5 which contains fluid 24, as indicated at reference character 1 a. In another exemplary embodiment, the compartment may be detachably connected to electrosurgical device 5, such as a canister which may be attached via threaded engagement with device 5. In yet another embodiment, the compartment may be configured to hold a pre-filled cartridge of fluid 24, rather than the fluid directly.
Also for example, with regards to alternative for the generator 6, an energy source, such as a direct current (DC) battery used in conjunction with inverter circuitry and a transformer to produce alternating current at a particular frequency, may comprise a portion of the electrosurgical device 5, as indicated at reference character 6 a. In one embodiment the battery element of the energy source may comprise a rechargeable battery. In yet another exemplary embodiment, the battery element may be detachably connected to the electrosurgical device 5, such as for recharging. The components of the system will now be described in further detail. From the specification, it should be clear that any use of the terms “distal” and “proximal” are made in reference from the user of the device, and not the patient.
Flow rate controller 11 controls the rate of flow from the fluid source 1. Preferably, the rate of fluid flow from fluid source 1 is based upon the amount of RF power provided from generator 6 to electrosurgical device 5. Referring to
Throughout this disclosure, when the terms “boiling point of saline”, “vaporization point of saline”, and variations thereof are used, what is actually referenced for explanation purposes, is the boiling point of the water (i.e., 100° C.) in the saline solution given that the difference between the boiling point of normal saline (about 100.16° C.) and the boiling point of water is negligible.
P=ΔT/R+ρc ρ Q 1 ΔT+ρQ b h v (1)
where P=the total RF electrical power that is converted into heat.
Conduction. The term [ΔT/R] in equation (1) is heat conducted to adjacent tissue, represented as 70 in
This thermal resistance can be estimated from published data gathered in experiments on human tissue (see for example, Phipps, J. H., “Thermometry studies with bipolar diathermy during hysterectomy,” Gynaecological Endoscopy, 3:5-7 (1994)). As described by Phipps, Kleppinger bipolar forceps were used with an RF power of 50 watts, and the peak tissue temperature reached 320° C. For example, using the energy balance of equation (1), and assuming all the RF heat put into tissue is conducted away, then R can be estimated:
However, it is undesirable to allow the tissue temperature to reach 320° C., since tissue will become desiccated. At a temperature of 320° C., the fluid contained in the tissue is typically boiled away, resulting in the undesirable tissue effects described herein. Rather, it is preferred to keep the peak tissue temperature at no more than about 100° C. to inhibit desiccation of the tissue. Assuming that saline boils at about 100° C., the first term in equation (1) (ΔT/R) is equal to (100−37)/6=10.5 watts. Thus, based on this example, the maximum amount of heat conducted to adjacent tissue without any significant risk of tissue desiccation is 10.5 watts.
Referring again to
Convection. The second term [ρcρQ1ΔT] in equation (1) is heat used to warm up the saline without boiling the saline, represented as 72 in
The onset of boiling can be predicted using equation (1) with the last term on the right set to zero (no boiling) (ρQbhv=0), and solving equation (1) for Q1 leads to:
Q 1 =[P−ΔT/R]/ρc ρ ΔT (2)
This equation defines the line shown in
Boiling. The third term [ρQbhv] in equation (1) relates to heat that goes into converting the water in liquid saline to water vapor, and is represented as 74 in
A flow rate of only 1 cc/min will absorb a significant amount of heat if it is completely boiled, or about ρQbhv=(1)(1/60)(2,000)=33.3 watts. The heat needed to warm this flow rate from body temperature to 100° C. is much less, or ρcρQ1ΔT=(1) (4.1)(1/60)(100−37)=4.3 watts. In other words, the most significant factor contributing to heat transfer from a wet electrode device can be fractional boiling. The present invention recognizes this fact and exploits it.
Fractional boiling can be described by equation (3) below:
If the ratio of Qb/Q1 is 0.50 this is the 50% boiling line 78 shown in
As indicated previously in the specification, use of a fluid to couple energy to tissue inhibits undesirable effects such as sticking, desiccation, smoke production and char formation. Tissue desiccation, which occurs if the tissue temperature exceeds 100° C. and all the intracellular water boils away, is particularly undesirable as it leaves the tissue extremely dry and much less electrically conductive.
As shown in
Another control strategy that can be used for the electrosurgical device 5 is to operate device 5 in the region T<100° C., but at high enough temperature to shrink tissue containing Type I collagen (e.g., walls of blood vessels, bronchi, bile ducts, etc.), which shrinks when exposed to about 85° C. for an exposure time of 0.01 seconds, or when exposed to about 65° C. for an exposure time of 15 minutes. An exemplary target temperature/time for tissue shrinkage is about 75° C. with an exposure time of about 1 second. A determination of the high end of the scale (i.e., when the fluid reaches 100° C.) can be made by the phase change in the fluid from liquid to vapor. However, a determination at the low end of the scale (e.g., when the fluid reaches, for example, 75° C. for 1 second) requires a different mechanism as the temperature of the fluid is below the boiling temperature and no such phase change is apparent. In order to determine when the fluid reaches a temperature that will facilitate tissue shrinkage, for example 75° C., a thermochromic material, such as a thermochromic dye (e.g., leuco dye), may be added to the fluid. The dye can be formulated to provide a first predetermined color to the fluid at temperatures below a threshold temperature, such as 75° C., then, upon heating above 75° C., the dye provides a second color, such as clear, thus turning the fluid clear (i.e., no color or reduction in color). This color change may be gradual, incremental, or instant. Thus, a change in the color of the fluid, from a first color to a second color (or lack thereof) provides a visual indication to the user of the electrosurgical device 5 as to when a threshold fluid temperature below boiling has been achieved. Thermochromic dyes are available, for example, from Color Change Corporation, 1740 Cortland Court, Unit A, Addison, Ill. 60101.
It is also noted that the above mechanism (i.e., a change in the color of the fluid due to a dye) may also be used to detect when the fluid reaches a temperature which will facilitate tissue necrosis; this generally varies from about 60° C. for an exposure time of 0.01 seconds and decreasing to about 45° C. for an exposure time of 15 minutes. An exemplary target temperature/time for tissue necrosis is about 55° C. for an exposure time of about 1 second.
In order to reduce coagulation time, use of the electrosurgical device 5 in the region T=100° C. of
For consistent tissue effect, it is desirable to control the saline flow rate so that it is always on a “line of constant % boiling” as, for example, the line of the onset of boiling 76 or the 100% boiling line 80 or any line of constant % boiling located in between (e.g., 50% boiling line 78) as shown in
It should be noted, from the preceding equations, that the slope of any line of constant % boiling is known. For example, for the line of the onset of boiling 76, the slope of the line is given by (ρcρΔT), while the slope of the 100% boiling line 80 is given by 1/(ρcρΔT+ρhv). As for the 50% boiling line 78, for example, the slope is given by 1/(ρcρΔT+ρhv0.5).
If, upon application of the electrosurgical device 5 to the tissue, boiling of the fluid is not detected, such indicates that the temperature is less than 100° C. as indicated in the area of
Conversely, if upon application of the electrosurgical device 5 to the tissue, boiling of the fluid is detected, such indicates that the temperature is approximately equal to 100° C. as indicated in the areas of
With regards to the detection of boiling of the fluid, such may be physically detected by the user (e.g., visually by the naked eye) in the form of either bubbles or steam evolving from the fluid coupling at the electrode/tissue interface. Alternatively, such a phase change (i.e., from liquid to vapor or vice-versa) may be measured by a sensor which preferably senses either an absolute change (e.g., existence or non-existence of boiling with binary response such as yes or no) or a change in a physical quantity or intensity and converts the change into a useful input signal for an information-gathering system. For example, the phase change associated with the onset of boiling may be detected by a pressure sensor, such as a pressure transducer, located on the electrosurgical device 5. Alternatively, the phase change associated with the onset of boiling may be detected by a temperature sensor, such as a thermistor or thermocouple, located on the electrosurgical device 5, such as adjacent to the electrode. Also alternatively, the phase change associated with the onset of boiling may be detected by a change in the electric properties of the fluid itself. For example, a change in the electrical resistance of the fluid may be detected by an ohm meter; a change in the amperage may be measured by an amp meter; a change in the voltage may be detected by a volt meter; and a change in the power may be determined by a power meter.
Yet another control strategy which may be employed for the electrosurgical device 5 is to eliminate the heat conduction term of equation (1) (i.e., ΔT/R). Since the amount of heat conducted away to adjacent tissue can be difficult to precisely predict, as it may vary, for example, by tissue type, it may be preferable, from a control point of view, to assume the worst case situation of zero heat conduction, and provide enough saline so that if necessary, all the RF power could be used to heat up and boil the saline, thus providing that the peak tissue temperature will not go over 100° C. significantly. This is shown in the schematic graph of
Stated another way, if the heat conducted to adjacent tissue 70 is overestimated, the power P required to intersect the 100% boiling line 80 will, in turn, be overestimated and the 100% boiling line 80 will be transgressed into the T>>100° C. region of
Upon determination of the line of the onset of boiling 76, the 100% boiling line 80 or any line of constant % boiling there between, it is generally desirable to control the flow rate Q so that it is always on a particular line of constant % boiling for consistent tissue effect. In such a situation, flow rate controller 11 will adjust the flow rate Q of the fluid 24 to reflect changes in power P provided by the generator 6, as discussed in greater detail below. For such a use flow rate controller 11 may be set in a line of constant boiling mode, upon which the % boiling is then correspondingly selected.
As indicated above, it is desirable to control the saline flow rate Q so that it is always on a line of constant % boiling for consistent tissue effect. However, the preferred line of constant % boiling may vary based on the type of electrosurgical device 5. For example, if with use of the device 5, shunting through saline is not an issue, then it can be preferable to operate close to or directly on, but not over the line of the onset of boiling, such as 76 a in
Q 1 =K×P (4)
In essence, when power P goes up, the flow rate Q will be proportionately increased. Conversely, when power P goes down, the flow rate Q will be proportionately decreased.
The proportionality constant K is primarily dependent on the fraction of saline that boils, as shown in equation (5), which is equation (3) solved for K after eliminating P using equation (4), and neglecting the conduction term (ΔT/R):
Thus, the present invention provides a method of controlling boiling of fluid, such as a conductive fluid, at the tissue/electrode interface. In a preferred embodiment, this provides a method of treating tissue without use of tissue sensors, such as temperature or impedance sensors. Preferably, the invention can control boiling of conductive fluid at the tissue/electrode interface and thereby control tissue temperature without the use of feedback loops.
In describing the control strategy of the present invention described thus far, focus has been drawn to a steady state condition. However, the heat required to warm the tissue to the peak temperature (T) may be incorporated into equation (1) as follows:
P=ΔT/R+ρc ρ Q 1 ΔT+ρQ b h v +ρc ρ VΔT/Δt (6)
where ρcρVΔT/Δt represents the heat required to warm the tissue to the peak temperature (T) 68 and where:
Density of the saline fluid that gets hot but does not boil
(approximately 1.0 gm/cm3);
Specific heat of the saline (approximately 4.1 watt-sec/gm-° C.);
Volume of treated tissue
(T − T∞) the difference in temperature between the peak tissue
temperature (T) and the normal temperature (T∞) of the body
tissue (° C.). Normal temperature of the body tissue is generally
37° C.; and
(t − t∞) the difference in time to achieve peak tissue temperature
(T) and the normal temperature (T∞) of the body tissue (° C.).
The inclusion of the heat required to warm the tissue to the peak temperature (T) in the control strategy is graphically represented at 68 in
% Boiling and Flow Rate Q (cc/min) at RF Power P of 75 watts
Typical RF generators used in the field have a power selector switch to 300 watts of power, and on occasion some have been found to be selectable up to 400 watts of power. In conformance with the above methodology, at 0% boiling with a corresponding power of 300 watts, the calculated flow rate Q is 69.7 cc/min and with a corresponding power of 400 watts the calculated flow rate Q is 92.9 cc/min. Thus, when used with typical RF generators in the field, a fluid flow rate Q of about 100 cc/min or less with the present invention is expected to suffice for the vast majority of applications.
As discussed herein, RF energy delivery to tissue can be unpredictable and vary with time, even though the generator has been “set” to a fixed wattage. The schematic graph of
Combining the effects shown in
According to one exemplary embodiment of the invention, the control device, such as flow rate controller 11, receives a signal indicating the drop in actual power delivered to the tissue and adjusts the flow rate Q of saline to maintain the tissue/electrode interface at a desired temperature. In a preferred embodiment, the drop in actual power P delivered is sensed by the power measurement device 8 (shown in
Flow rate controller 11 of
An exemplary electrosurgical device of the present invention which may be used in conjunction with the system of the present invention is shown at reference character 5 a in
As shown in
Referring back to
As shown in
It is understood that shapes other than a sphere can be used for the contact element. Examples of such shapes include oblong or elongated shapes. However, as shown in
As shown in
Also as shown in
As for cavity 81, the internal diameter of cavity 81 surrounding electrode 25 is preferably slightly larger than the diameter of the sphere, typically by about 0.25 mm. This permits the sphere to freely rotate within cavity 81. Consequently, cavity 81 of sleeve 82 also preferably has a diameter in the range of about 1 mm to about 7 mm.
As best shown in
As best shown in
As shown in
As shown in
It should be understood that the particular geometry of fluid outlet opening provided by the fluid exit hole located at the distal end of device 5 a to the electrode is not critical to the invention, and all that is required is the presence of a fluid exit hole which provides fluid 24 as required. For example, fluid exit hole 26 may have an oval shape while electrode 25 has a different shape, such as a round shape.
As shown in
Turning to the proximal end of the tip (comprising electrode 25, spring 88 and sleeve 82) of the device 5 a and electrode 25, as shown in
While distal pinched region 86 and proximal pinched region 87 may be used solely to support electrode 25, in its position of use, the electrode may be further supported by a compression spring 88 as shown in
In addition to the above, spring 88 provides a multitude of functions and advantages. For example, the configuration of the distal pinched region 86, proximal pinched region 87 and spring 88 offers the ability to move electrode 25 distally and proximally within sleeve 82. As shown in
Conversely, upon application of electrode 25 against surface 22 of tissue 32 with sufficient force to overcome the compression force of the spring 88, spring 88 compresses and electrode 25 retracts proximally away from distal pinched region 86, in this case perimeter edge 92 of crimp 84, changing the position thereof. In the above manner, the contact element comprising electrode 25 is retractable into the cavity 81 of the housing provided by sleeve 82 upon the application of a proximally directed force against surface 42 of the portion 43 of electrode 25 extending distally beyond the distal opening 26 located at the distal end 83 of the housing and spring 88 functions as a retraction biasing member.
By making electrode 25 positionable in the above manner via spring 88, electrosurgical device 5 a can be provided with a damper mechanism which dampens the force of electrode 25 on tissue 32 being treated.
Furthermore, electrode 25 which can be positioned as outlined above can comprise a fluid flow rate adjustment mechanism which incrementally increases the area of fluid exit hole 26 and the corresponding fluid flow rate in response to the incremental proximal retraction of electrode 25. In such an instance, electrode 25 functions as a valve by regulating flow of fluid 24 through fluid exit hole 26.
In various embodiments, spring 88 may be used in conjunction with the distal pinched region 86 (e.g., crimp 84 comprising a single continuous circular pattern) to provide a fluid seal between electrode 25 and the distal pinched region 86 which stops fluid flow from the electrosurgical device 5 a. In this manner, the electrosurgical device 5 a may be used to provide both a wet electrode and dry electrode (i.e., when the fluid flow is on and off, respectively) with the energy and fluid provided sequentially in addition to simultaneously. The incorporation of a dry electrode function into the device may be desirable to provide a mechanism for electrosurgical cutting.
Furthermore, in various embodiments of electrosurgical device 5 a, an electrode 25 which can be positioned as outlined above can include a declogging mechanism. Such a mechanism can retract to provide access for unclogging fluid exit holes (e.g., 26 and 85), which may become flow restricted as a result of loose debris (e.g., tissue, blood) becoming lodged therein. For example, when a biasing force, such as from a handheld cleaning device (e.g., brush) or from pushing the distal tip against a hard surface such as a retractor, is applied to surface 42 of electrode 25 which overcomes the compression force of the spring 88 causing the spring 88 to compress and electrode 25 to retract, the tip of the handheld cleaning device may by extended into the fluid exit hole 26 for cleaning the fluid exit hole 26, perimeter edge 92, slot 85 and edge 91. Stated another way, electrode 25, which can be positioned as outlined, provides a methodology for declogging a fluid exit hole by increasing the cross-sectional area of the fluid exit hole to provide access thereto.
Additionally, in various embodiments of device 5 a, spring 88 comprises an electrical conductor, particularly when electrode 25, is retracted to a non-contact position (i.e., not in contact) with sleeve 82.
In other embodiments, proximal pinched region 87 may comprise one or more crimps similar to distal pinched region 86, such that electrode 25 is retained in sleeve 82 both distally and proximally by the crimps. Also, in other embodiments, sleeve 82 may be disposed within shaft 17 rather than being connected to the distal end 53 of shaft 17. Also, in still other embodiments, sleeve 82 may be formed unitarily (i.e., as a single piece or unit) with shaft 17 as a unitary piece.
As best shown in
In locations where shaft 17 and sleeve 82 are electrically conductive (for device 5 a, preferably shaft 17 and sleeve 82 are completely electrically conductive and do not comprise non-conductive portions) an electrical insulator 90 (i.e., comprising non-conductive or insulating material) preferably surrounds shaft 17 and sleeve 82 along substantially its entire exposed length (e.g., the portion outside the confines of the handle 20), terminating a short distance (e.g., at the proximal onset of crimp 84 or less than about 3 mm) from distal end 83 of sleeve 82. Insulator 90 preferably comprises a shrink wrap polymer tubing.
As with the other electrosurgical devices described within, a input fluid line 4 b and a power source, preferably comprising generator 6 preferably providing RF power via cable 9, are preferably fluidly and electrically coupled, respectively, to the tip portion 45 of the electrosurgical device 5 a.
As indicated above, device 5 a comprises a monopolar device. A monopolar device has a first electrode, often referred to as the active electrode, and a second electrode, often referred to as the indifferent or return electrode. For electrosurgical device 5 a, electrode 25 is the first electrode, and a ground pad dispersive electrode located on the patient, typically on the back or other suitable anatomical location, is the second electrode. Preferably, both electrodes are electrically coupled to generator 6 to form an electrical circuit. Preferably the active electrode is coupled to generator 6 via a wire conductor from insulated wire cable 9 to the outer surface 18 of shaft 17 within the confines of handle 20 a, 20 b, typically through a switch 15 a.
In some embodiments, shaft 17 may be made of an electrical non-conducting material except for a portion at its distal end 53 that comes in contact with sleeve 82. This portion of shaft 17 that contacts sleeve 82 should be electrically conducting. In this embodiment, the wire conductor from insulated wire cable 9 extends to this electrically conducting portion of shaft 17. In still other embodiments, shaft 17 may completely comprise a non-conducting material as where the wire conductor from insulated wire cable 9 extends directly to sleeve 82.
With respect to the fluid coupling, fluid 24 from the fluid source 1 preferably is communicated from fluid source 1 through a flexible, polyvinylchloride (PVC) outlet fluid line 4 a to a flexible, polyvinylchloride (PVC) inlet fluid line 4 b connected to electrosurgical device 5 a. Outlet fluid line 4 a and inlet fluid line 4 b are preferably connected via a male and female mechanical fastener configuration; a preferred such connection is a Luer-Lok® connection from Becton, Dickinson and Company. The lumen of the inlet line is then preferably interference fit over the outside diameter of shaft 17 to provide a press fit seal there between. An adhesive may be used there between to strengthen the seal. Fluid 24 is then communicated down lumen 23 of shaft 17 through lumen 89 and cavity 81 of sleeve 82 where it is expelled from around and on the exposed surface 42 of electrode 25. This provides a wet electrode for performing electrosurgery.
As shown in
Another exemplary electrosurgical device is shown at reference character 5 b in
In the above manner, tip portion 45 now includes a first tissue treating surface (e.g., distal end spherical surface 42) and a second tissue treating surface (e.g., side surface 40). As discussed above, preferably the first tissue treating surface is configured for blunt dissection while the second tissue treating surface is configured for coagulation. Additionally, tip portion 45 also has a third tissue treating surface (e.g., surface 41) located between the first tissue treating surface (e.g., surface 42) and a second tissue treating surface (e.g., surface 39). Furthermore, tip portion 45 also has a fourth tissue treating surface (e.g., surface 47) located proximal and adjacent to surface 39.
With device 5 a, when electrode 25 is placed directly in contact with surface 22 of tissue 32, tissue 32 may occlude fluid flow from fluid exit holes 26, 85 located at the distal end of device 5 a. Consequently, for device 5 b fluid exit holes 93, 94 may be located in the cylindrical side portion 39 of sleeve 82, either proximal or adjacent to electrode 25, and either in addition to or as an alternative to fluid exit holes 26, 85.
As shown in
Preferably, holes 93, 94 each comprise more than one hole which are equally spaced radially in a circular pattern around the longitudinal axis 31 of tip portion 45, and more particularly sleeve 82. More preferably, holes 93, 94 each comprise four discrete holes equally spaced 90 degrees around the cylindrical side portion 39 of sleeve 82. Preferably holes 93, 94 have a diameter in the range between and including about 0.1 mm to 1.0 mm, and more preferably have a length in the range between and including about 0.2 mm to 0.6 mm.
Electrode 25, which can be positioned as outlined above, can comprise not only a valve for regulating fluid flow from the fluid exit holes, such as fluid exit hole 26, but also comprise a valve which while opening one fluid flow exit simultaneously closes another fluid flow exit. For example, as electrode 25 retracts proximally, fluid exit hole 26 is opened while fluid exit hole 93 is closed. Stated another way, an electrode 25 which can be positioned as outlined above can provide a mechanism for altering the size and/or location of the fluid exit holes during use of electrosurgical device 5 b which may be necessary, for example, to direct fluid to a particular tissue location or balance fluid flow among the fluid exit outlets.
Thus, as shown in
The holes 94, 93 in the cylindrical sleeve 82 of the overall electrode surface are intended to assure that fluid 24 is provided to the smooth, less rough, atraumatic sides of the electrode that are used to produce tissue coagulation and hemostasis (e.g., surfaces 40 and 47) rather than blunt dissection (e.g., surfaces 41 and 42). The most distal portion of the device may have a more rough, but also wetted, electrode surface that can blunt dissect as well as coagulate tissue.
The electrode configuration shown in
As shown in
This technique can also be used on other parenchymal organs such as the pancreas, the kidney, and the lung. In addition, it may also be useful on muscle tissue and subcutaneous fat. It's use can also extend to benign tumors, cysts or other tissue masses found in the urological or gynecological areas. It would also enable the removal of highly vascularized tumors such as hemangiomas.
For the devices disclosed herein, the presence of various fractions of boiling can be visually estimated by the naked eye, or by detecting changes in electrical impedance.
In certain embodiments, the contact element, here electrode 25 may also comprise a material pervious to the passage of fluid 24, therethrough, such as a porous material (e.g., metal, polymer or ceramic) to provide the tortuous pathways 59. In these embodiments, the porous structure of electrode 25 allows fluid 24 to not only pass around electrode 25 on the outer porous surface 42 to be expelled, but also allows fluid 24 to pass through electrode 25, to be expelled. According to the invention, all or a portion of the electrodes or any particular electrodes for treating tissue 32 may comprise a material pervious to the passage of fluid 24 therethrough as disclosed herein.
Where the contact element and sleeve provide electrodes for treating tissue and compromise a porous material, preferably the porous material further comprises porous metal. Porous sintered metal is available in many materials (such as, for example, 316L stainless steel, titanium, Ni-Chrome) and shapes (such as cylinders, discs, plugs) from companies such as Porvair, located in Henderson, N.C.
Porous metal components can be formed by a sintered metal powder process or by injection molding a two-part combination of metal and a material that can be burned off to form pores that connect (open cell) to each other. With sintering, for example, typically solid particles of material are placed in a mold under heat and pressure such that the outer surface of the particles soften and bond to one another with the pores comprising the interstices between the particles. Alternatively, when porosity is formed by burning off material, it is not the interstice between the particles which provides the porosity as with sintering, but rather a partial evisceration of the material generally provided by the removal of a component with a lower melt temperature than the burn off temperature.
While the electrode provided by contact element and/or sleeve preferably comprises an electrically conductive material such as metal, a non-electrically conductive porous contact element and/or sleeve, such as porous polymers and ceramics, can be used to replace an electrically conductive contact element and/or sleeve. While the porous polymers and ceramics are generally non-conductive, they may also be used to conduct the RF energy through the porous polymer and ceramic thickness and porous surface to the tissue to be treated by virtue of conductive fluid 24 contained within the plurality of interconnected tortuous pathways 59.
Preferably the tortuous passages in the porous materials have a pore size (cross-sectional dimension) in the range between and including about 2.5 micrometers (0.0025 mm) to 500 micrometers (0.5 mm) and more preferably has pore size in the range between and including about 10 micrometers (0.01 mm) to 120 micrometers (0.12 mm). Even more preferably, the porous material has a pore size in the range between and including about 20 micrometers (0.02 mm) to 80 micrometers (0.08 mm).
In addition to possibly providing a more uniform distribution of fluid 24, the porous materials also may provide other advantages. For example, when the electrode surfaces, such as surfaces 40, 41, 42 and 47, in contact with the surface 22 of tissue 32 are porous and dissipate fluid 24, tissue 32 is less apt to stick to surfaces 40, 41, 42 and 47 of the electrode as compared to the situation where the surfaces 40, 41, 42 and 47 are not porous. In addition, by providing fluid 24 to surfaces 40, 41, 42 and 47 through tortuous pathways 59, heated and/or electrified fluid 24 can now be provided more uniformly to surfaces 40, 41, 42 and 47, which may result in a wider tissue treatment region as compared to when the surfaces are not porous.
Preferably the porous material provides for the wicking (i.e., drawing in of fluid by capillary action or capillarity) of the fluid 24 into the pores of the porous material. In order to promote wicking of the fluid 24 into the pores of the porous material, preferably the porous material, and in particular the surface of the tortuous pathways, is hydrophilic. The porous material may be hydrophilic with or without post treating (e.g., plasma surface treatment such as hypercleaning, etching or micro-roughening, plasma surface modification of the molecular structure, surface chemical activation or crosslinking), or made hydrophilic by a coating provided thereto, such as a surfactant.
Though not preferable, it is not necessary that fluid coupling 30 of fluid 24 be present in between the metal electrode surfaces (e.g., 40, 41, 42) and tissue 32 at all locations of tissue treatment and there may be points of direct tissue contact by the electrode surfaces without any fluid coupling 30 therebetween. In such an instance, the convective cooling of the metal electrode by flowing saline is often sufficient to keep the metal electrode and tissue contacting the metal electrode at or below a temperature of 100° C. In other words, heat may be also first dissipated from tissue 32 to the electrodes by conduction, then dissipated from the electrodes to the fluid 24 by convection.
Preferably the relationship between the material for electrodes particularly their surfaces (e.g., 40, 41, 42, 47), and fluid 24 throughout the various embodiments should be such that the fluid 24 wets the surface of the electrodes to form a continuous thin film coating thereon (for example, see
For clarification, while it is known that the contact angle θ may be defined by the preceding equation, in reality contact angle θ is determined by a various models to an approximation. According to publication entitled “Surface Energy Calculations” (dated Sep. 13, 2001) from First Ten Angstroms (465 Dinwiddie Street, Portsmouth, Va. 23704), there are five models which are widely used to approximate contact angle θ and a number of others which have small followings. The five predominate models and their synonyms are: (1) Zisman critical wetting tension; (2) Girifalco, Good, Fowkes, Young combining rule; (3) Owens, Wendt geometric mean; (4) Wu harmonic mean; and (5) Lewis acid/base theory. Also according to the First Ten Angstroms publication, for well-known, well characterized surfaces, there can be a 25% difference in the answers provided for the contact angle θ by the models. Also for clarification, any one of the five predominate models above which calculates a contact angle θ within a particular range of contact angles θ or the contact angle θ required of a particular embodiment of the invention should be considered as fulfilling the requirements of the embodiment, even if the remaining four models calculate a contact angle θ which does not fulfill the requirements of the embodiment.
The effects of gravity and surface tension tend to wick the fluid 24, here saline, around the circumference of the cylindrical sleeve 82 to preferably cover the entire active electrode surface. More specifically, the effects of gravity and surface tension on fluid 24 which is located on the electrode surfaces may be modeled by the Bond number NBO. Bond number NBO measures the relationship of gravitational forces to surface tension forces and may be expressed as:
For a Bond number NBO=1, the droplet diameter is equal to about 0.273 cm or about 2.7 mm, which is in the same order of magnitude as the preferred size of the electrode. For the purposes of the present invention, preferably Bond number NBO for a droplet of fluid 24 on a surface of electrode 25 is preferably less than 1.
Another tip portion of an exemplary electrosurgical device 5 c of the present invention which may be used in conjunction with the system of the present invention is shown at reference character 45 in
As shown in
Also as shown in
Further continuing with
As shown in
Also as shown in
As shown, electrode 25 preferably comprises a plurality of longitudinally directed recesses 64 and, more specifically, four recesses 64 equally spaced 90 degrees around the shank 46 and/or neck portion 56, both proximal of cylindrical portion 39. As best shown in
In use, when tissue 32 overlies and occludes the fluid outlet opening 55 of recess 64 for a portion of its longitudinal length, thus inhibiting fluid 24 from exiting therefrom, fluid 24 from recess 64 may still be expelled from the electrosurgical device 5 c after flowing longitudinally in the channel 64 to a remote location where the channel 64 is unoccluded and uninhibited to fluid flow exiting therefrom.
However, in certain instances, it may be possible that the recess 64 may be occluded by tissue 32 completely along its longitudinal length, thus completely inhibiting fluid flow from exiting through opening 55. In order to overcome this problem, at least a portion of electrode 25 may comprise a material pervious to the passage of fluid 24, therethrough, such as a porous material described above.
As shown in
Where electrode 25 comprises a porous material, recess 64 may be either supplemented with or replaced by the plurality of tortuous, interconnected passages 59 formed in the porous material as shown in
In other embodiments of the invention, recess 64 may comprise cross-sectional shapes other than rectangular shapes. For example, as shown in
As indicated above, the use of device 5 c, and in particular recesses 64, for the distribution of fluid 24 is generally preferred to the fluid exit holes 93, 94 of device 5 b in particularly deep tissue crevices 97 where tissue 32 can occlude fluid flow from the fluid exit holes 93, 94 located in the cylindrical portion 39 of electrode 25. Also, since holes 93, 94 are not presented with a declogging mechanism, such as provided for such as fluid exit holes 26 and 85, holes such as 93, 94 that can be simply occluded by ordinary tissue/electrode contact will sooner or later become irreversibly clogged.
As shown in
Another tip portion of an exemplary electrosurgical device 5 e of the present invention which may be used in conjunction with the system of the present invention is shown at reference character 45 in
Also as shown in
Another tip portion of an exemplary electrosurgical device 5 f of the present invention which may be used in conjunction with the system of the present invention is shown at reference character 45 in
Also as shown in
Another tip portion of an exemplary electrosurgical device 5 g of the present invention which may be used in conjunction with the system of the present invention is shown at reference character 45 in
Another tip portion of an exemplary electrosurgical device 5 h of the present invention which may be used in conjunction with the system of the present invention is shown at reference character 45 in
As shown, finger portion 65 is rectilinear and forms an L-hook with an angle of about 90 degrees relative to the longitudinal axis 31 of the tip portion 45, particularly shank 45. However, finger portion may be formed at angles other than 90 degrees. For example. finger portion 65 may be formed at any angle in the range between and including about 60 degrees relative to the tip portion 45 to about 180 degrees relative to the tip portion 45, or any other range of angles or particular angle inclusive therein (e.g., 75°, 105°, 120°, 135°, 180°, 90°-135°, 90°-180°.
Among other things, electrode 25 preferably comprises a knuckle portion 61 comprising a rounded protuberance having a raised prominence on the posterior (back) surface portion 62 of electrode 25. Also as shown, knuckle portion 61 also comprises a rounded protuberance having a raised prominence on the lateral surface portion 75 of electrode 25. Among other things, posterior knuckle surface portion 62 and lateral knuckle surface portion 75 formed by knuckle portion 61 are configured for coagulation and stasis (e.g., hemostasis, aerostasis) of tissue 32.
Key to device 5 g is the cross-sectional dimension of the knuckle Z to the cross-section dimension of the finger F. When comparing the functions of blunt or electrosurgical dissection and coagulation/hemostasis, the coagulation/hemostasis portion of electrode 25 preferably comprises a greater surface area than the blunt or electrosurgical dissection portion of electrode 25.
As shown in
Preferably, the cross-sectional dimension Z of the knuckle portion 61 is in the range between and including about 1.6 to 3.3 times greater than the cross-section dimension F of the finger portion 65, with typical dimensions comprising the ratios of 2.5 mm to 1.5 mm (1.6 times) and 2.5 mm to 0.75 mm (3.3 times). Even more preferably, the cross-sectional dimension Z of the knuckle portion 61 is in the range between and including about 2 to 2.5 times greater than the cross-section dimension F of the finger portion 65, with typical dimensions comprising the ratios of 2.5 mm to 1.25 mm (2 times) and 2.5 mm to 1 mm (2.5 times).
From the above dimensions, the ratio of the surface area of the knuckle portion 61 to the surface area of the distal end (e.g., surface 42) of the finger portion 65 may be determined to an approximation using a formula for half the area of a sphere. For the above dimensions, preferably the surface area of the knuckle portion 61 is in the range between and including about 2.8 times to 11 times greater than the surface area the distal end of the finger portion 65. More preferably, the surface area of the knuckle portion 61 is in the range between and including about 4 times to 6.2 times greater than the surface area the distal end of the finger portion 65.
Also as shown in
Turning to use of the devices, similar to device 5 b, device 5 c is particularly useful to a surgeon performing a liver resection. Once the outer capsule of the liver is scored with a dry bovie blade along the planned line of resection the distal tip of tip portion 45 is painted back and forth along the line, with radio frequency power and the flow of fluid 24 on, resulting in coagulation of the liver parenchyma. Once the tissue is coagulated under and around the electrode surface 42 and, as the device 5 c enters a crevice 97, surface 40, surface 42 of electrode 25 is used to blunt dissect the coagulated parenchyma. Blunt dissection of the coagulated parenchyma is performed by continuous abrading or splitting apart of the parenchyma with the substantially the same back and forth motion as coagulation and with the device 5 c being held substantially in the same orientation as for coagulation of the liver parenchyma. However, with blunt dissection, the surgeon typically applies more force to the tissue. In various embodiments, once the liver parenchyma is coagulated, blunt dissection may be performed with or without the radio frequency power (i.e., on or off) and/or with or without the presence of fluid 24.
In addition to liver resections, device 5 h are particularly useful to a surgeon performing a laparoscopic cholecystectomy (abbr. “lap chole”) for the case of, for instance, either acute cholecystitis or an intrahepatic gallbladder in that the device provides multi-functional uses. More particularly, device 5 h is useful to the surgeon for coagulation and dissection of an inflamed serosal layer of tissue 32 between the liver and gallbladder, which may include tough, fibrous, highly vascular connecting tissue between the organs.
For coagulation, device 5 h may be positioned in at least three different orientations. For the first orientation, as shown in
For the second orientation, as shown in
Where the surgeon has pre-coagulated tissue 32, the surgeon may dissect tissue 32 with simultaneous mechanical traction (i.e., the process of drawing or pulling of tissue 32 with a mechanical device) with anterior (i.e., front) surface portion 66 of finger portion 65 which is configured, among other things, to engage and restrain tissue 32. More specifically, the surgeon may hook tissue 32 for dissection against the surface portion 66 of finger portion 65 and apply traction to tissue 32, then dissect tissue 32.
Since tissue 32 has been coagulated, dissection may be performed with or without the radio frequency power (i.e., on or off) and/or with or without the presence of fluid 24. Where tissue 32 is dissected without fluid 24, but with the radio frequency power on and with the generator set to the coagulation mode, the process of dissecting may be referred to as “hook and cook” in the art. While dissecting in this manner is fast, it suffers from the problems of significant arcing, the production of smoke and char, and the possibility of inadvertent perforation of the gall bladder wall. Alternatively, dissecting without the radio frequency power on may eliminate the problems of arcing, the production of smoke and char, and the possibility of inadvertent perforation, but may result in bleeding if tissue 32 is not sufficiently coagulated. In order to overcome the aforementioned issues, dissection of tissue 32 with traction may be performed similar to coagulation (i.e., in the presence of both radio frequency power and fluid 24). However, this alternative typically requires more time than “hook and cook”.
With regards to the sequence of events for dissect tissue 32 with traction and using the “hook and cook” technique (i.e., without fluid 24), the surgeon first engages tissue 32 on the surface portion 66 of finger portion 65. The surgeon then applies traction to the engaged tissue 32. Once complete, the surgeon checks for proper position then applies the radio frequency power. Upon application of the radio frequency power, tissue 32 yields, separates and breaks. The surgeon then turns the radio frequency power off. This process may then be repeated numerous times as the surgeon incrementally dissects tissue 32 along a length in step-wise fashion.
Certain embodiments of the invention may be particularly configured for bipolar devices. For example, an exemplary bipolar electrosurgical device of the present invention which may be used in conjunction with the system of the present invention is shown at reference character 5 i in
In certain embodiments, an exemplary bipolar surgical device of the present invention may comprise, among other things, multiple, substantially parallel, arms. As shown in
Preferably the arms of device 5 i (comprising shafts 17 a, 17 b) are retained in position relative to each other by a mechanical coupling device comprising a collar 95 and inhibited from separating relative to each other. Collar 95 preferably comprises a polymer (e.g., acrylonitrile-butadiene-styrene or polycarbonate) and is preferably located on the distal portion of the arms. More preferably, the collar 95 is located proximal the distal ends 53 a, 53 b of the shafts 17 a, 17 b. Preferably the collar 95 comprises two apertures 96 a, 96 b, preferably comprising opposing C-shapes, configured to receive a portion of the shafts 17 a, 17 b which are preferably snap-fit therein. Once the collar 95 is connected to the shafts 17 a, 17 b, preferably by a snap-fit connection, the collar 95 may be configured to slide along the length of the shafts 17 a, 17 b as to adjust or vary the location of the collar 95 on the shafts 17 a, 17 b. Alternatively, the location of the collar 95 may be fixed relative to the shafts 17 a, 17 b by welding, for example.
Device 5 i comprises a first arm tip portion 45 a and a second arm tip portion 45 b. As shown, preferably both first arm tip portion 45 a and second arm tip portion 45 b are each individually configured identical to tip portion 45 of device 5 a. As a result, device 5 i has two separate, spatially separated (by empty space) contact elements preferably comprising electrodes 25 a, 25 b.
As shown in
Similar to device 5 a, for device 5 i fluid 24 is communicated from a fluid source 1 within the lumens 23 a, 23 b of the shafts 17 a, 17 b through the lumens 89 a, 89 b and cavities 81 a, 81 b of the sleeves 82 a, 82 b where it is expelled from around and on the surface 42 a, 42 b of the electrodes 25 a, 25 b.
As with use of device 5 a, with use of device 5 i fluid couplings 30 a, 30 b preferably comprising discrete, localized webs and more preferably comprising a triangular shaped web or bead portion providing a film of fluid 24 is provided between surface 22 of tissue 32 and electrodes 25 a, 25 a. When the user of electrosurgical device 5 i places electrodes 25 a, 25 b at a tissue treatment site and moves electrodes 25 a, 25 b across surface 22 of tissue 32, fluid 24 is expelled around and on surfaces 42 a, 42 b of electrodes 25 a, 25 b at the distal ends 83 a, 83 b of sleeves 82 a, 82 b and onto surface 22 of tissue 32 via couplings 30 a, 30 b. At the same time, RF electrical energy, shown by electrical field lines 130, is provided to tissue 32 at tissue surface 22 and below tissue surface 22 into tissue 32 through fluid couplings 25 a, 25 b.
As with device 5 a, the fluid 24, in addition to providing an electrical coupling between the electrosurgical device 5 i and tissue 32, lubricates surface 22 of tissue 32 and facilitates the movement of electrodes 25 a, 25 b across surface 22 of tissue 32. During movement of electrodes 25 a, 25 b, electrodes 25 a, 25 b typically slide across the surface 22 of tissue 32, but also may rotate as electrodes 25 a, 25 b move across surface 22 of the tissue 32. Typically the user of electrosurgical device 5 i slides electrodes 25 a, 25 b across surface 22 of tissue 32 back and forth with a painting motion while using fluid 24 as, among other things, a lubricating coating. Preferably the thickness of the fluid 24 between the distal end surface of electrodes 25 a, 25 b and surface 22 of tissue 32 at the outer edge of couplings 30 a, 30 b is in the range between and including about 0.05 mm to 1.5 mm. More preferably, fluid 24 between the distal end surface of electrodes 25 a, 25 b and surface 22 of tissue 32 at the outer edge of coupling 30 a, 30 b is in the range between and including about 0.1 mm to 0.3 mm. Also preferably, in certain embodiments, the distal end tip of electrode 25 contacts surface 22 of tissue 32 without any fluid 24 in between.
As shown in
In order to counteract the loss of energy through bridge 27, once enough energy has entered bridge 27 to boil fluid 24 of bridge 27, the loss of RF energy correspondingly decreases with the loss of bridge 27. Preferably energy is provided into fluid 24 of bridge 27 by means of heat dissipating from tissue 32.
Thus, where a high % boiling of conductive fluid 24 of bridge 24 is created, the loss of RF energy through bridge 27 may either be reduced or eliminated because all the fluid 24 of bridge 27 boils off or a large fraction of boiling creates enough disruption in the continuity of bridge 27 to disrupt the electrical circuit through bridge 27. Thus, one control strategy of the present invention is to reduce the presence of a conductive fluid shunt by increasing the % boiling of the conductive fluid.
Another embodiment of a bipolar device is shown at 5 j in
Also as shown for device 5 j, outlet opening 124 for fluid line 120 is preferably spaced uniformly between electrodes 25 a, 25 b such that conductive fluid 24 expelled from outlet opening 124 may form a fluid coupling comprising bridge 27 between tissue surface 22 surface 42 a, 42 b of each of electrodes 25 a, 25 b. If a collar 95 is used with device 5 j preferably the collar contains a third C-shaped aperture to accommodate fluid line 120 there through.
In certain embodiments, at least a portion of the length of the two arms (comprising shafts 17 a, 17 b and sleeves 82 a, 82 b) or the two arms and fluid line 120 of device 5 j may be located and housed within the cavity 132, typically a lumen, of an elongated hollow tubular enclosure 128 as shown in
The elongated tubular enclosure 128 may comprise, for example a wrapping, such as shrink wrap polymer film or shrink wrap polymer tubing, which may be formed and located with the surface of cavity 132 against insulators 90 a, 90 b upon the application of heat thereto. In this manner, elongated members shafts 17 a, 17 b or shafts 17 a, 17 b and fluid line 120, are retained in position relative to each other and inhibited from separating relative to each other.
Another embodiment of a bipolar device is shown at 5 k in
As best shown in
The circular recesses 142 a, 142 b formed between the proximal circular flange portions 136 a, 136 b and distal circular flange portions 138 a, 138 b provides a receptacle for receiving semi-circular interlocking tab portions 144 a, 144 b of distal end portions 146 a, 146 b of shaft portions 134 a, 134 b.
During assembly, the interlocking tab portions of one of the shaft portions are first located in a portion of recesses 142 a, 142 b of electrodes 25 a, 25 b. In other words, for example, electrodes 25 a, 25 b may be first assembled with semi-circular interlocking tab portions 144 a of distal end portion 146 a of shaft portion 134 a which then occupy a first semi-circular portion of circular recesses 142 a, 142 b. Then, once electrodes 25 a, 25 b have been properly seated with respect to the first shaft portion, here 134 a, the interlocking tab portions of the second shaft portion, here 144 b of shaft 134 b, are located in the remaining semi-circular portion of circular recesses 142 a, 142 b. After electrodes 25 a, 25 b have been properly seated with respect to both shaft portions 134 a, 134 b and all remaining components are properly located, shaft portions 134 a, 134 b and handle portions 20 a, 20 b may be assembled to one another by use of, for example an adhesive (e.g., cyanoacrylate) or welding.
As best shown in
Electrodes 25 a, 25 b of device 5 k are preferably coupled to generator 6 via wire conductors 38 a, 38 b of insulated wires 21 a, 21 b. At their distal ends, conductors 38 a, 38 b may be coupled to electrodes 25 a, 25 b by means of first being inserted into the lumens 148 a, 148 b of hollow metal tubes 150 a, 150 b, such as hypo-tubes, then crimping tubes 150 a, 150 b. Tubes 150 a, 150 b are then preferably inserted and retained in proximal end receptacles 152 a, 152 b of electrodes 25 a, 25 b by an interference fit. Alternatively, tubes 150 a, 150 b may be eliminated and wire conductors 38 a, 38 b may be coupled to electrodes 25 a, 25 b by welding.
For device 5 k, conductive fluid 24 is preferably provided by means of a lumen 122 of a separate fluid line 120, preferably comprising either a metal (e.g., stainless steel hypo-tubing) or polymer (e.g., PVC tubing) material, extending distally and substantially parallel within the lumen of the shaft comprising shaft portions 134 a, 134 b.
Similar to device 5 j, in order to minimize the risk of clogging lumen 122 at the distal end outlet opening 124 of fluid line 120, as shown, preferably distal end 126 of fluid line 120 is located proximal to the distal end of device 5 k and more preferably, proximal to spherical surface portions 42 a, 42 b and cylindrical surface portions 40 a, 40 b of electrodes 25 a, 25 b, or other tissue treating surfaces of electrodes as the electrode configurations vary.
Also similar to device 5 j, for device 5 k the outlet opening 124 for fluid line 120 is preferably spaced uniformly between electrodes 25 a, 25 b such that conductive fluid 24 expelled from outlet opening 124 may form a fluid coupling comprising bridge 27 between tissue surface 22 and surface 42 a, 42 b of each of electrodes 25 a, 25 b.
The effect of the bipolar devices of the present invention on tissue may be varied by changing the separation distance between the contact elements. Consequently, as shown in
Furthermore, as shown, arms 117 a, 117 b themselves are preferably hinged or pivotal around pivots 110 a and 110 b, which preferably comprising pins, which divide arms 117 a, 117 b into proximal arm portions 118 a, 118 b and distal arm portions 112 a, 112 b. Distal arm portions 112 a, 112 b are preferably connected by a linkage 113 which keeps distal arm portions 112 a, 112 b substantially parallel to one another with use of the device 5 l. As shown, linkage 113 comprises a bar 114 fixed to distal arm portion 112 b and having an elongated opening 116 therein. Linkage also comprises a pin 115 fixed to distal arm portion 112 a which moves along and within the opening 116 during use of the device 5 l with the changing of the separation distance between electrodes 25 a, 25 b. For device 5 l, tip portions 45 a, 45 b may particularly comprise the configuration disclosed with device 5 i.
Bipolar devices 5 i-5 l are particularly useful as non-coaptive tissue coagulators given they do not grasp tissue. Devices 5 i-5 l are particularly useful to surgeons to achieve hemostasis after dissecting through soft tissue as part of hip or knee arthroplasty. The tip portions 45 a, 45 b can be painted over the raw, oozing surface 22 of tissue 32 to seal tissue 32 against bleeding, or focused on individual larger bleeding vessels to stop vessel bleeding. The devices 5 i-5 l are also useful to stop bleeding from the surface of cut bone tissue as part of any orthopedic procedure that requires bone to be cut. Bipolar devices 5 i-5 l are particularly useful for these applications over a monopolar device 5 a as a much greater surface area 22 of tissue 32 may be treated in an equivalent period of time and with better controlled depth of the treatment.
One or more of the features of the previously described system can be built into a custom RF generator. This embodiment can provide one or more advantages. For example, this type of system can save space and reduce overall complexity for the user. This system can also enable the manufacturer to increase the power delivered into low impedance loads, thereby further reducing the time to achieve the desired tissue effects. This changes the curve of
To effectively treat thick tissues, it can be advantageous to have the ability to pulse the RF power on and off. Under some circumstances, the temperature deep in tissue can rise quickly past the 100° C. desiccation point even though the electrode/tissue interface is boiling at 100° C. This manifests itself as “popping,” as steam generated deep in the tissue boils too fast and erupts toward the surface. In one embodiment of the invention, a switch is provided on the control device or custom generator to allow the user to select a “pulse” mode of the RF power. Preferably, the RF power system in this embodiment is further controlled by software.
It may be desirable to control the temperature of the conductive fluid before its release from the electrosurgical device. In one embodiment, a heat exchanger is provided for the outgoing saline flow to either heat or chill the saline. The heat exchanger may be provided as part of the electrosurgical device or as part of another part of the system, such as within enclosure 14. Pre-heating the saline to a predetermined level below boiling reduces the transient warm-up time of the device as RF is initially turned on, thereby reducing the time to cause coagulation of tissue. Alternatively, pre-chilling the saline is useful when the surgeon desires to protect certain tissues at the electrode/tissue interface and treat only deeper tissue. One exemplary application of this embodiment is the treatment of varicose veins, where it is desirable to avoid thermal damage to the surface of the skin. At the same time, treatment is provided to shrink underlying blood vessels using thermal coagulation. The temperature of the conductive fluid prior to release from the surgical device can therefore be controlled, to provide the desired treatment effect.
In another embodiment, the flow rate controller is modified to provide for a saline flow rate that results in greater than 100% boiling at the tissue treatment site. For example, selection switch 12 of flow rate controller 11 (shown in
Some embodiments of the invention can provide one or more advantages over current electrosurgical techniques and devices. For example, the invention preferably achieves the desired tissue effect (for example, coagulation, cutting, and the like) in a fast manner. In a preferred embodiment, by actively controlling the flow rate of saline, both in quantity (Q vs. P) and location (for example, using gutters to direct fluid distally to tissue, using holes to direct flow of fluid, or other similar methods) the electrosurgical device can create a hot non-desiccating electrode/tissue interface and thus a fast thermally induced tissue coagulation effect.
The use of the disclosed devices can result in significantly lower blood loss during surgical procedures such as liver resections. Typical blood loss for a right hepatectomy can be in the range of 500-1,000 cubic centimeters. Use of the devices disclosed herein to perform pre-transection coagulation of the liver can result in blood loss in the range of 50-300 cubic centimeters. Such a reduction in blood loss can reduce or eliminate the need for blood transfusions, and thus the cost and negative clinical consequences associated with blood transfusions, such as prolonged hospitalization and a greater likelihood of cancer recurrence. Use of the device can also provide improved sealing of bile ducts, and reduce the incidence of post-operative bile leakage, which is considered a major surgical complication.
The invention can, in some embodiments, deliver fast treatment of tissue without using a temperature sensor built into the device or a custom special-purpose generator. In a preferred embodiment, there is no built-in temperature sensor or other type of tissue sensor, nor is there any custom generator. Preferably, the invention provides a means for controlling the flow rate to the device such that the device and flow rate controller can be used with a wide variety of general-purpose generators. Any general-purpose generator is useable in connection with the fluid delivery system and flow rate controller to provide the desired power; the flow rate controller will accept the power and constantly adjust the saline flow rate according to the control strategy. Preferably, the generator is not actively controlled by the invention, so that standard generators are useable according to the invention. Preferably, there is no active feedback from the device and the control of the saline flow rate is “open loop.” Thus, in this embodiment, the control of saline flow rate is not dependent on feedback, but rather the measurement of the RF power going out to the device.
For purposes of the appended claims, the term “tissue” includes, but is not limited to, organs (e.g., liver, lung, spleen, gallbladder), highly vascular tissues (e.g., liver, spleen), soft and hard tissues (e.g., adipose, areolar, bone, bronchus-associated lymphoid, cancellous, chondroid, chordal, chromaffin, cicatricial, connective, elastic, embryonic, endothelial, epithelial, erectile, fatty, fibrous, gelatiginous, glandular, granulation, homologous, indifferent, interstitial, lymphadenoid, lymphoid, mesenchymal, mucosa-associated lymphoid, mucous, muscular, myeloid, nerve, osseous, reticular, scar, sclerous, skeletal, splenic, subcutaneous) and tissue masses (e.g., tumors).
While a preferred embodiment of the present invention has been described, it should be understood that various changes, adaptations and modifications can be made therein without departing from the spirit of the invention and the scope of the appended claims. The scope of the invention should, therefore, be determined not with reference to the above description, but instead should be determined with reference to the appended claims along with their full scope of equivalents. Furthermore, it should be understood that the appended claims do not necessarily comprise the broadest scope of the invention which the Applicant is entitled to claim, or the only manner(s) in which the invention may be claimed, or that all recited features are necessary.
All publications and patent documents cited in this application are incorporated by reference in their entirety for all purposes.
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|Citing Patent||Filing date||Publication date||Applicant||Title|
|US8961506||9 May 2014||24 Feb 2015||Advanced Cardiac Therapeutics, Inc.||Methods of automatically regulating operation of ablation members based on determined temperatures|
|U.S. Classification||606/41, 606/49|
|International Classification||A61B18/00, A61B18/12, A61B18/14, A61B, A61B18/04|
|Cooperative Classification||A61B2018/00601, A61B2018/00404, A61B2018/00875, A61B18/1445, A61B2018/00791, A61B2018/0063, A61B2018/00065, A61B2018/00702, A61B2018/00809, A61B18/1442, A61B2018/00029, A61B18/14, A61B2018/1422, A61B2018/1417, A61B2018/1861, A61B18/1482, A61B2218/002|
|European Classification||A61B18/14F2, A61B18/14, A61B18/14F, A61B18/14R|
|6 Sep 2006||AS||Assignment|
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